Prospective Registry to Evaluate Outcomes of NanoBone® Bone Graft in Acute Trauma

Description

This multicenter prospective patient registry was developed with the aim of documenting how orthopedic surgeons are utilizing the NanoBone products in acute trauma cases along with relevant patient outcomes. These outcomes include radiographic measures such as fracture healing, instrumentation integrity, and clinical outcomes (symptom and function improvement) based on investigator and patient-based outcome assessments.

Conditions

Fractures, Bone

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Study Overview

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Study Details

Study overview

This multicenter prospective patient registry was developed with the aim of documenting how orthopedic surgeons are utilizing the NanoBone products in acute trauma cases along with relevant patient outcomes. These outcomes include radiographic measures such as fracture healing, instrumentation integrity, and clinical outcomes (symptom and function improvement) based on investigator and patient-based outcome assessments.

Multicenter Prospective Registry to Evaluate Use and Outcomes of NanoBone® Bone Graft Substitute in Acute Trauma Patients

Prospective Registry to Evaluate Outcomes of NanoBone® Bone Graft in Acute Trauma

Condition
Fractures, Bone
Intervention / Treatment

-

Contacts and Locations

Madison

SSM Health St. Mary's Hospital, Madison, Wisconsin, United States, 53715

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Subjects at least 18 years old at the time of injury
  • 2. Acute fractures, resulting from blunt or penetrating trauma
  • * In the extremities or pelvis
  • * Requiring surgery
  • * Treated emergently, delayed or staged up to 4 weeks from the date of injury
  • * Where bone grafting is clinically indicated
  • 1. Certain fracture locations (these apply to non-unions as well)
  • * Hand - metacarpals, phalanges
  • * Forefoot - metatarsals, phalanges
  • * Skull
  • * Spine
  • 2. Fractures requiring definitive fracture stabilization beyond the initial 4 weeks from the date of injury
  • 3. Pathologic fractures secondary to malignancy
  • 4. Subjects unable to follow recommended post-operative plan and complete follow ups
  • 5. Subjects unable to complete patient reported outcome measures

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Artoss Inc.,

Mitchell D Kuhl, DO, PRINCIPAL_INVESTIGATOR, SSM Health

Study Record Dates

2026-12-01